– Compliance officers should not wait for boards’ engagement of experts

Government regulators have advised for decades that effective Compliance Programs begin at the top with the Board and cascade down through the executive leadership and the compliance officer to all employees. The OIG and American Health Lawyers Association (AHLA) issued three communications that underscore the Board compliance duties and responsibilities. The most recent is “Practical Guidance for Health Care Governing Boards on Compliance Oversight” which advised Boards to have compliance expertise available to make sure they meet all fiduciary duties and obligations in overseeing corporate compliance.

Carrie Kusserow, with 20 years experience as a compliance officer and consultant who brought organizations through CIA mandates, has found the Practical Guidance particularly significant. It calls for Boards to engage Compliance Experts to assist them in meeting their obligations and it is noteworthy that it provides almost identical language to the language used in CIAs regarding Boards’ use of Compliance Experts. In cases where the OIG finds that the Board has not been providing the proper oversight of the compliance program, the OIG really nails the organization down in the CIA mandates, which now require personal certifications of board members. She suggests that Compliance Officers should review recent CIAs to learn what the OIG considers as best practices for a Board in engaging a Compliance Expert to be on call for advisory services.

Steve Forman, a CPA with more than twenty years experience as a Compliance Officer, compliance consultant, and has been engaged on many occasions as Board Compliance Expert. He notes that the CIA mandates for Boards to engage a Compliance Expert because most board compliance oversight lacks members who are experts in compliance. Whereas Board Audit Committees always include “financially literate” members, most Board committees providing compliance program oversight lack members who are “compliance literate.” The result is relatively few boards have with anyone with compliance expertise to assist in proper oversight and support for the Compliance Program. His best advice for Boards is to include someone who is “compliance literate” that knows what questions to be asked and assess program effectiveness.

For more information on this subject, contact Carrie Kusserow (ckusserow@strategicm.com)

Richard P. Kusserow served as DHHS Inspector General for 11 years. He currently is CEO of Strategic Management Services, LLC (SM), a firm that has assisted more than 3,000 organizations and entities with compliance related matters. The SM sister company, CRC, provides a wide range of compliance tools including sanction-screening.

The OIG Work Plan sets forth various projects including OIG audits and evaluations that are underway or planned to be addressed during the fiscal year and beyond. Projects included in the Work Plan span the Department and include CMS. The OIG also plans work related to issues that cut across departmental programs, including state and local governments’ use of federal funds. At the end of December, the OIG announced two new projects led by the Office of Evaluation and Inspection beginning in 2019. They are:

T-MSIS Data Assessment: Usefulness of National Data to Monitor Opioid Prescribing in Medicaid. Although all States have been submitting T-MSIS data, it does not mean the data are complete and without complete data, it cannot be used as a national dataset to help Medicaid manage critical issues such as the opioid crisis. The will OIG determine whether T-MSIS contains the data necessary to identify recipients of opioid prescriptions through Medicaid who may be at risk of opioid abuse nationally. The OIG intends to interview states to determine the challenges they face, if any, in submitting the data necessary to identify and prevent beneficiary harm from opioid misuse.

States’ Compliance with FFS and MCO Provider Enrollment Requirements. The OIG noted that provider enrollment is a key program integrity tool to protect Medicaid from fraudulent and abusive providers. The 21st Century Cures Act requires states to enroll all Medicaid providers, both those in Medicaid fee-for-service (FFS) and managed care organizations (MCOs). This study, by the OIG, is mandated by the Cures Act and will survey state Medicaid agencies about their enrollment of FFS and managed care providers and implementation of required provider enrollment screening activities.

Richard P. Kusserow served as DHHS Inspector General for 11 years. He currently is CEO of Strategic Management Services, LLC (SM), a firm that has assisted more than 3,000 organizations and entities with compliance related matters. The SM sister company, CRC, provides a wide range of compliance tools including sanction-screening.

Those on Preclusion List are prohibited from MA Plan or Part D sponsor payment

Effective April 2019, under a final rule published by CMS, Part D sponsors, or their pharmacy benefit manager must screen against the Preclusion List and reject any pharmacy claim prescribed by an individual or entity on the Preclusion List. Additionally, effective April 2019, MA plans must deny payment for a health care item or service furnished by an individual or entity on the list. Plans and sponsors must also notify impacted beneficiaries who received care or a prescription from a provider on the Preclusion List in the last twelve months. The list includes those who are currently revoked from Medicare; are under an active reenrollment bar, where CMS has determined that the underlying conduct is detrimental to the Medicare program; or have engaged in behavior for which CMS could have revoked the prescriber and determined the underlying conduct would have led to the revocation. Such conduct includes, but is not limited to, felony convictions and OIG exclusions. Only health care plans approved by CMS will have access to the Preclusion List. MA plans and Part D sponsors will be required to access the list through an Enterprise Identity Data Management (EIDM) account with CMS. The List will be updated around the first business day of each month. CMS indicated that individuals or entities appearing on the List of Excluded Individuals/Entities (LEIE) and/or the System for Award Management (SAM) list would also be placed on the Preclusion List.

Richard P. Kusserow served as DHHS Inspector General for 11 years. He currently is CEO of Strategic Management Services, LLC (SM), a firm that has assisted more than 3,000 organizations and entities with compliance related matters. The SM sister company, CRC, provides a wide range of compliance tools including sanction-screening.

For the new year, compliance officers should recall Congress passing into law the Eliminating Kickbacks in Recovery Act of 2018 (EKRA), which became effective October 24, 2018. It applies to Medicare and Medicaid, as well as many commercial health insurance plans. It has the effect of eliminating “safe harbors” used by clinical labs in marketing services. The law was intended to be part of the effort to target the national opioid crisis. It makes it a criminal offense to solicit or receive any remuneration, directly or indirectly, in return for referring a patient or patronage to a recovery home, clinical treatment facility or clinical laboratory; or to offer or pay a kickback to “induce” a referral of an individual to a recovery home, clinical treatment facility or clinical laboratory, or in exchange for an individual using the services of a recovery home, clinical treatment facility or clinical laboratory. Penalties for each violation can include a fine of up to $200,000 and imprisonment of up to 10 years. The law has seven “safe harbors,” some of which are similar to the safe harbors under the federal Anti-Kickback Statute that is generally applicable to Medicare and Medicaid services, however the safe harbor for employees and independent contractors under the law expressly excludes from safe harbor protection any payment made to an employee or independent contractor that is determined or varies by:

the number of individuals referred;

the number of tests or procedures performed; or

the amount billed or received.

The EKRA adds an all payor (public and private) provision that enables the federal government to monitor provider arrangements intended to generate business for any laboratory services, not only those related to individuals in treatment for substance abuse disorders, payable by a federal health care program or commercial health insurer.

Richard P. Kusserow served as DHHS Inspector General for 11 years. He currently is CEO of Strategic Management Services, LLC (SM), a firm that has assisted more than 3,000 organizations and entities with compliance related matters. The SM sister company, CRC, provides a wide range of compliance tools including sanction-screening.